NCT03490708

Brief Summary

56 participants with Mucinoses will be selected to receive treatment of tranilast. After a period of time ,the investigators can determine the efficacy of the drug by detecting the the thickness and area of skin before and after treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2018

Longer than P75 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 6, 2018

Status Verified

February 1, 2018

Enrollment Period

4.2 years

First QC Date

February 4, 2018

Last Update Submit

April 1, 2018

Conditions

Mucinoses

Keywords

MucinosesTranilast

Outcome Measures

Primary Outcomes (1)

  • Measure the volume change of skin lesions by ultrasound

    During tranilast (0.1g each time, three times a day, 12 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective

    This experiment will last for 12 months

Study Arms (1)

Tranilast

EXPERIMENTAL

Subjects who were treated with tranilast

Drug: Tranilast

Interventions

TranilastDRUG

Subjects will be treated with tranilast

Tranilast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and histopathological examination has been proved to be Mucinoses;
  • Ultrasound and magnetic resonance detection found that the skin was thickened.

You may not qualify if:

  • With a liver or kidney disease, or accompanied by a severe infection;
  • Poor control of primary disease;
  • With mental disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mucinoses

Interventions

tranilast

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2018

First Posted

April 6, 2018

Study Start

April 1, 2018

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

April 6, 2018

Record last verified: 2018-02